CEFUROXIME NORMON 750 mg POWDER AND SOLVENT FOR INJECTION

Introduction

Package Leaflet: Information for the User

Cefuroxima Normon 750 mg Powder and Solvent for Solution for Injection EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Cefuroxima Normon and what is it used for
2. What you need to know before you start using Cefuroxima Normon
3. How to use Cefuroxima Normon
4. Possible side effects

5 Storage of Cefuroxima Normon

1. Contents of the pack and further information

1. What is Cefuroxima Normon and what is it used for

Cefuroxima Normon is an antibiotic used in both adults and children. It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential that you follow the instructions regarding dosage, administration, and duration of treatment as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Cefuroxima Normon is used to treat infectionsof:

• the lungs or chest,
• the urinary tract,
• the skin and soft tissues,
• the abdomen.

Cefuroxima Normon is also used to:

• prevent infections during surgical procedures.

2. What you need to know before you start using Cefuroxima Normon

Do not use Cefuroxima Normon:

• If you are allergic (hypersensitive)to cefalosporinsor to any of the other components of this medicine (listed in section 6).
• If you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxima or any other cephalosporin antibiotic.

Be cautious with Cefuroxima Normon

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxima treatment. Seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Consult your doctor beforestarting treatment with cefuroxima; if you think this may affect you, you should not be given this medicine.

Warnings and precautions

You should be aware of certain symptoms such as allergic reactions and gastrointestinal disorders, such as diarrhea, while receiving cefuroxima. This will reduce the risk of potential complications. See ("Symptoms to be aware of") in section 4. If you have had an allergic reaction to other antibiotics, such as penicillin, you may also be allergic to cefuroxima.

If you need a blood or urine test

Cefuroxima may affect the results of sugar tests in urine and blood analyses (Coombs test). If you are having tests:

Inform the person taking the samplethat you are receiving cefuroxima.

Using Cefuroxima Normon with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you might take any other medicines.

Some medicines may affect how cefuroxima works or make it more likely that you will have side effects. These include:

• aminoglycoside antibiotics,
• "water pills" (diuretics), such as furosemide,
• probenecid,
• oral anticoagulants.

Consult your doctorif you think this may affect you. You may need additional checks to monitor kidney function while taking cefuroxima.

Contraceptive pill

Cefuroxima may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while being treated with cefuroxima, you should also use barrier contraceptive methods(such as condoms). Ask your doctor for advice.

Pregnancy, breastfeeding, and fertility

Tell your doctor before being treated with cefuroxima:

• if you are pregnant, think you may be pregnant, or plan to become pregnant,
• if you are breastfeeding.

Your doctor will weigh the benefits of being treated with cefuroxima against the risks to your child.

Driving and using machines

Do not drive or use machinery if you do not feel well.

Cefuroxima Normon contains sodium

This medicine contains 42 mg of sodium (a major component of table salt/cooking salt) per vial. This is equivalent to 2.1% of the maximum recommended daily sodium intake for an adult.

3. How to use Cefuroxima Normon

Cefuroxima is usually administered by a doctor or nurse. It can be administered by injection directly into a vein or into a muscle.

The usual dose

Your doctor will decide the optimal dose of cefuroxima for you, based on: the severity and type of infection, whether you are being treated with other antibiotics, your weight and age, and how well your kidneys are working.

Newborns (0 - 3 weeks)

For every kg of the newborn's weight, they will be given 30 to 100 mg of cefuroxima per day, divided into two or three doses.

Infants (over 3 weeks) and children

For every kg of the infant's or child's weight, they will be given 30 to 100 mg of cefuroxima per day, divided into three or four doses.

Adults and adolescents

750 mg to 1,500 mg of cefuroxima sodium, two, three, or four times a day.

Patients with kidney problems

If you have a kidney problem, your doctor may change your dose. Consult your doctorif you are affected by this problem.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to be aware of

A small number of people who received cefuroxima developed a severe allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).

• Severe allergic reaction. The signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing,
• Skin rash, which can cause blisters, resembling small targets(dark spot in the center surrounded by a lighter area, with a dark ring around the edge),
• Widespread skin rashwith blisters and skin peeling. (These can be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis),
• Fungal infectionsin rare cases, medicines like cefuroxima can cause an overgrowth of fungi (Candida) in the body, leading to fungal infections (such as thrush).

Contact a doctor or nurse immediately if you experience any of these symptoms.

Common side effects

May affect up to 1 in 10 people:

• pain at the injection site, swelling, and redness along the vein.

Contact your doctorif you experience any of these symptoms.

Common side effects that may appear in blood tests:

• increase in some substances (enzymes) produced by the liver,
• changes in white blood cell count (neutropenia or eosinophilia),
• low levels of red blood cells (anemia).

Uncommon side effects

May affect up to 1 in 100 people:

• skin rash, itching, urticaria (hives),
• diarrhea, nausea, stomach pain.

Contact your doctorif you experience any of these symptoms.

Uncommon side effects that may appear in blood tests:

• low levels of white blood cells (leucopenia),
• increase in bilirubin (a substance produced by the liver),
• positive Coombs test.

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is unknown:

• fungal infections,
• high temperature (fever),
• allergic reactions,
• inflammation of the colon (large intestine), causing diarrhea, usually with blood and mucus,
• stomach pain,
• inflammation in the kidneys and blood vessels,
• rapid destruction of red blood cells (hemolytic anemia),
• skin rash, which can cause blisters, resembling small targets (dark spot in the center surrounded by a lighter area, with a dark ring around the edge) erythema multiforme.

Contact your doctorif you experience any of these symptoms.

Side effects that may appear in blood tests:

• decrease in the number of platelets in the blood (cells that help blood clot - thrombocytopenia),
• increase in urea and creatinine levels in the blood.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxima Normon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Store below 25°C.

Keep the vial in the outer packaging to protect from light.

For the storage conditions of the reconstituted/diluted solution, see "Information for Healthcare Professionals" at the end of the leaflet.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cefuroxima Normon

The active substance is cefuroxime sodium.

Each 750 mg vial contains 813 mg of cefuroxime sodium, equivalent to 750 mg of cefuroxime.

The solvent ampoule contains water for injections.

Appearance of Cefuroxima Normon and contents of the pack

Cefuroxime sodium is a white or almost white powder.

It is presented in 17 ml Type II colorless glass vials, closed with a gray chlorobutyl rubber stopper and sealed with a "flip-off" cap.

Pack of 1 vial and 1 solvent ampoule.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet:July 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62908/P_62908.html

Information for Healthcare Professionals

Reconstitution instructions

For single use only. Discard unused solution.

Intramuscular use

Add 3 ml for cefuroxime 750 mg powder for solution for injection (see Table "Volumes for addition and concentrations of the solution, which may be useful when fractionated doses are required").

Gently shake to obtain an opaque suspension.

Intravenous use

Dissolve in water for injections using at least 6 ml for cefuroxime 750 mg. Gently shake to obtain a clear solution.

Table Volumes for addition and concentrations of the solution, which may be useful when fractionated doses are required

** The resulting volume of the cefuroxime solution in the reconstitution medium is increased by the drug displacement factor resulting in the listed concentrations in mg/ml.

Compatibility

Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

The stability of cefuroxime sodium in sodium chloride 0.9% solution for injection and in glucose 5% solution for injection is not affected by the presence of sodium hydrocortisone phosphate.

Storage of cefuroxime injectable:

Store below 25°C.

Keep the vial in the outer packaging to protect it from light.

Reconstituted solution: From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 25°C protected from light, unless the reconstitution has been carried out under controlled and validated conditions.

Incompatibilities

Solutions containing cefuroxime should not be mixed with or added to solutions containing other products that are not those mentioned above (see "Compatibility").

Cefuroxime powder for solution for injection should not be mixed in the same syringe with aminoglycoside antibiotics.

The pH of sodium bicarbonate injection at 2.74% p/v significantly affects the color of the solutions, and therefore, this solution is not recommended for the dilution of cefuroxime powder for solution for injection.